In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Device specific risks that fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of patient instability of the shoulder joint devices is most likely due to the patient's underlying conditions.This device is used for treatment, not diagnosis no device evaluation pending.
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It was reported that patient experienced a revision surgery of shoulder devices due to instability.The patient was having an "unstable" shoulder joint device and the surgeon determined to put the reverse in with more tension, thus upsized the humeral implants by 5mm.The liner and adapter tray were removed using appropriate devices, a trial was done using a plus 5mm adapter tray insert and 0mm liner to mate with the 42mm glenosphere.The surgeon felt comfortable with the upsize.The patient surgical outcome was noted to be successful.There is no indication or complaint that the device malfunctioned.No additional information has been provided.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00935 and 1038671-2017-00936.
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